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Director – Quality GCP
Director ‚Äì Quality GCPScorpion Therapeutics • Boston, MA, United States
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Director – Quality GCP

Director – Quality GCP

Scorpion Therapeutics • Boston, MA, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

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Role Summary

Director Quality GCP responsible for strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre-clinical and clinical programs. Requires 75% on-site presence and collaboration with teams in Boston and Basel.

Responsibilities

  • Primary GCP Quality contact for identified vendors and investigator sites supporting clinical programs and other GCP quality events (e.g., potential serious breach assessments, CAPAs).
  • Author key GCP quality SOPs and serve as reviewer for other quality (GxP) procedures.
  • Develop a risk-based GCP compliance program.
  • Support initiation, review, and closure of quality events and associated CAPA, Change Action, and Effectiveness plans.
  • Develop and provide GCP and other GxP training as applicable.
  • Ensure appropriate qualification of vendors and compliant vendor management with regular assessments / audits; may conduct GCP audits (vendors and sites).
  • Ensure audit observations are communicated, tracked, and remediated.
  • Provide QA GCP review and feedback on regulatory submissions.
  • Lead and participate in inspection readiness activities for regulatory inspections internally and at clinical sites.
  • Interface with internal departments and external vendors on technical / quality subjects.

Qualifications

  • BS Degree in Chemistry, Pharmacy, Biology or a related life science, or combination of BS Degree with relevant Quality and Technical experience.
  • Minimum of 16 years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations.
  • Knowledge and experience of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.). GLP experience is a plus.
  • Able to provide a solution-minded approach and flexibility to emerging challenges.
  • Able to balance priorities and multi-task against competing demands.
  • Proven ability to work in a fast-paced, matrixed, start-up environment.
  • Hands-on leadership with a practical, solution-focused mindset.
  • Understanding of drug development and program management is preferred.

    • Skills

  • GCP and GxP quality management
  • Vendor qualification and audit management
  • Regulatory submissions support and inspection readiness
  • Risk-based compliance program development
  • Training program development and delivery
  • Cross-functional collaboration in a matrixed environment

    • Education

  • BS in Chemistry, Pharmacy, Biology or related life science (or equivalent combination with relevant quality experience)

    • #J-18808-Ljbffr

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